Assessment of Fluid Responsiveness in Patients After Cardiac Surgery

Completed

• Conditions: Hemodynamics; Patient Monitoring

• Registration Number: NCT02571465
• Lead Sponsor: Triemli Hospital

Brief Summary

To overcome the limited accuracy of functional hemodynamic parameters such as stroke volume and pulse pressure variation (SVV and PPV) during spontaneous breathing, a Passive Leg Raising (PLR) manoeuvre has been suggested as a reliable predictor of fluid responsiveness.

Aim of this study was to evaluate fluid responsiveness using SVV, PPV and PLR during the transition from controlled to spontaneous breathing in cardiac surgery patients

Detailed Description

In patients after elective off-pump CABG are enrolled hemodynamic measurements are performed in the postoperative period upon arrival in the ICU using a PiCCO2 system (Pulsion Medical Systems, Munich, Germany).

Controlled fluid challenges (500 ml) are done at 3 time-points:

A) during controlled mechanical ventilation B) during pressure support ventilation with spontaneous breathing and C) after extubation.

Stroke volume (SV), SVV and PPV as well as standard hemodynamic parameters (MAP = mean arterial pressure, HR = heart rate) are assessed.

A PLR is performed before fluid administration at all 3 time points. A positive response is defined as an increase in SV\>15 %.

Prediction of fluid responsiveness will be tested by AUC (area under the receiver operating characteristic - ROC - curve).

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-10-07
• Study First Submitted QC: 2015-10-07
• Study First Posted: 2015-10-08
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-14
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• preserved left ventricular function
• regular heart rhythm

Exclusion Criteria

• emergency procedures
• intra- and extra-cardial shunts
• aortic and tricuspid valve insufficiencies
• peripheral arterial occlusive disease

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stroke volume increase > 15%	20 min	Stroke volume increase defines fluid responsiveness

Trial Locations

Locations (1)

Triemli City Hospital; 🇨🇭 Zurich, Switzerland